Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

Not Applicable

Completed

• Conditions: Chronic Endometritis
• Interventions: Drug: Dead Sea Peloid Gel

• Registration Number: NCT02680275
• Lead Sponsor: Scientific Center for Family Health and Human Reproduction Problems, Russia

Brief Summary

This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.

Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.

Detailed Description

Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-09
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2016-02-10
• Last Update Submitted: 2016-02-10
• Study First Posted: 2016-02-11
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Women with miscarriage associated with chronic endometritis
• Women without mental disorders able to swallow tablets

Exclusion Criteria

Clinical diagnosis of:

• sexually transmitted diseases
• endometrium hyperplasia and/or polyps
• uterina fibroids
• endocrine disorders
• trombophilia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doxycycline,Dead Sea Peloid Gel,placebo	Dead Sea Peloid Gel	1. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by Dead Sea Peloid Gel , 60 ml per day fo 12 days, intravaginally 2. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by placebo gel, 60 ml per day fo 12 days, intravaginally

Primary Outcome Measures

Name	Time	Method
The prevalence of spontaneous pregnancy the first year after treatment	during first year

Secondary Outcome Measures

Name	Time	Method
The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.	during 3 months

Trial Locations

Locations (1)

Scientific Center for Family Health and Human Reproduction Problems; 🇷🇺 Irkutsk, Russian Federation